Human Factors for Combination Products

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Understand the definitions and key concepts of human factors and combination products.

Recognize the regulatory and standards landscape for combination products.

Conduct comprehensive risk assessments to identify potential hazards.

Integrate risk management processes using the ISO14971 framework.

Perform formative assessments to evaluate early design concepts.

Develop and implement study designs for human factors evaluation.

Integrate ergonomics into the design of combination products.

Conduct summative assessments and interpret results to enhance product safety and usability.

Prepare summary documentation for regulatory submissions.

Understand how regulatory agencies evaluate human factors and ergonomics requirements.

KEY TOPICS

Regulatory and Standards Overview

EMA & FDA

IEC62366

TRAINER

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

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Video Invitation

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